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Sitagliptin Cardiovascular Outcome Study (0431-082 AM1) (TECOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00790205
First received: November 11, 2008
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

This is a clinical trial designed to assess the cardiovascular outcome of long term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in patients with Type 2 Diabetes Mellitus having a history of cardiovascular disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Sitagliptin phosphate
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization). [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, or nonfatal stroke). [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Time to all-cause mortality. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Time to congestive heart failure. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Change in renal function over time. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 14000
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin phosphate Drug: Sitagliptin phosphate
sitagliptin phosphate, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily
Other Names:
  • MK-0431
  • Januvia®
Placebo Comparator: Placebo Comparator Drug: Placebo
Placebo tablet matching the 50 mg or 100 mg sitagliptin phosphate tablet, orally, once daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has Type 2 Diabetes Mellitus
  • Patient's HbA1c is between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin
  • Patient has preexisting cardiovascular disease

Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or ketoacidosis.
  • Patient is not able to take sitagliptin
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00790205     History of Changes
Other Study ID Numbers: 0431-082, 2008_523
Study First Received: November 11, 2008
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013